MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 3; PROSTHESIS, HIP

Catalog Number	574201030
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported in a clinical study that a patient underwent a hip revision approximately seven months post implantation due to implant loosening and malalignment.Attempts have been made and no further information is available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.The stem's position is based upon the surgeon's discretion and it is unknown if the loosening caused the malalignment.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 3
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20155579
• Report Number: 0001822565-2024-02869
• Device Sequence Number: 19892418
• Product Code: LZO
• UDI-Device Identifier: 00889024509023
• UDI-Public: (01)00889024509023(17)250731(10)3032214
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 574201030
• Device Lot Number: 3032214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male